Impact of a Specific Training Program on the Neuromodulation of Pain in Fibromyalgia Subjects (DOUFISPORT)

• ClinicalTrials.gov Identifier: NCT02486965
• Recruitment Status: Unknown
• First Posted: July 1, 2015
• Last Update Posted: January 18, 2019
• Sponsor: University Hospital, Brest
• Information provided by (Responsible Party): University Hospital, Brest

Tracking Information

• First Submitted Date: February 26, 2015
• First Posted Date: July 1, 2015
• Last Update Posted Date: January 18, 2019
• Study Start Date: October 2015
• Estimated Primary Completion Date: October 2019 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 30, 2015): Pain as assessed by Visual analog scale [ Time Frame: baseline to 24 months ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 30, 2015)

• salivary cortisol [ Time Frame: baseline to 24 months ]
  three times : 3th visit at Day 0, 4th visit between month 6 and 9, 5th visit at month 24
• heart rate variability [ Time Frame: baseline to 24 months ]
  three times : 2th visit at Day -7, 4th visit between month 6 and 9, 5th visit at month 24
• Fibromyalgia Impact Questionnaire (FIQ) [ Time Frame: baseline to 24 months ]
• Hospital Anxiety Depression Scale (HADS) [ Time Frame: baseline to 24 months ]
• Pressure Pain Threshold (PSS) [ Time Frame: baseline to 24 months ]
• International Physical Activity Questionnaire (IPAQ) [ Time Frame: baseline to 24 months ]
• Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: baseline to 24 months ]
• Saint-Antoine Pain Questionnaire (SAPQ) [ Time Frame: baseline to 24 months ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Impact of a Specific Training Program on the Neuromodulation of Pain in Fibromyalgia Subjects
• Official Title: Impact of a Specific Training Program on the Neuromodulation of Pain in Fibromyalgia Subjects

Brief Summary

Fibromyalgia affects 1.4 now 2.2% of the general population whose symptom is the presence of widespread pain in all four quadrants of the body. Currently, there is no causal treatment of fibromyalgia syndrome.

The aim of this study is the evaluation of a specific training program on controls of pain in fibromyalgia patients by balancing the stress axis.

The primary endpoint is the improvement in the Visual Analogue Scale VAS difference) measured during the test of the thermode (difference between the average VAS measured between the 10th and 40th second of P1 and the average VAS measured between the 10th and 40th of the second P3) between D0 (3rd consultation) and M24 (5th consultation - end of study visit), which will be compared in the two groups..Salivary cortisol is also tested.

Detailed Description

A specific training program under the guidance of a physiotherapist, a professor of Adapted Physical Activity (APA) and individualized whose objective is to strengthen the parasympathetic tone and modulate the reactivity of the sympathetic system and the report of the Hypothalamic-Pituitary-Adrenal (HPA) axis.This training program consists of three sessions of 45 minutes of physical activity per week for 2 years. The exercise intensity is initially very low and will be gradually increased according to your abilities and your tolerance to stress. A 6-Minute Walk Test (6MWT) will be carried out by the physiotherapist and by Professor APA, every 6 months to monitor the progression. For tracking the training program, a phone call is scheduled every week during the first 3 months, then a phone call every 15 days during the following months until the end of the study.Evaluation of neuromodulation of pain will be measured thanks to thermodeTest , experimental method implementing a tonic thermal pain using a "Peltier type Thermode" 3 cm2 model TSA II and immersion in a bath of cold water.

Participants will be randomly assigned to 2 groups, "Training" group or "Control" group.

The control group is a training program supervised by physical therapists and teachers in Adapted Physical Activity, identical to the active program in its follow-up, but the intensity of the sessions is lower.

Study schedule :

• 1st visit : screening visit at D-30
• 2nd visit : inclusion at D-7
• 3rd visit at D0
• 4st visit between M6 and M9
• 5th visit at M24

The patients included in the study will receive in addition to the training program, taking into bio-psycho-social multidisciplinary.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Supportive Care
• Condition: Fibromyalgia

Intervention

• Device: thermode (TSA-II model)
  thermal stimulation with test thermode
• Other: Adapted Physical Activity
• Other: Physical activity

Study Arms

• Experimental: training group

  The training program consists of three sessions of 45 minutes of physical activity per week for 2 years. During the first 6-9 months, two individual workouts, supervised by a physiotherapist and a session in Living.

  Depending on the capacity and exercise tolerance of the patient, patients realize the second phase of training until 2 years of the study: three exercise sessions from 45 to 60 minutes per week of which group session led by a professor of Adapted Physical Activity (APA) and 2 autonomous sessions.

  Thermal stimulation with test thermode Thermic stimulations (tonic heat pain stimulation and cold-pressor test) are used to test excitatory and inhibitory pain mechanisms

  Interventions:

  • Device: thermode (TSA-II model)
  • Other: Adapted Physical Activity
  • Other: Physical activity
• Placebo Comparator: control group
  A training program supervised by physical therapists and teachers in Adapted Physical Activity, identical to the active program in its follow-up, but the intensity of the sessions is lower than that of the training group
  Intervention: Other: Adapted Physical Activity

• Publications *: Le Fur Bonnabesse A, Cabon M, L'Heveder G, Kermarrec A, Quinio B, Woda A, Marchand S, Dubois A, Giroux-Metges MA, Rannou F, Misery L, Bodéré C. Impact of a specific training programme on the neuromodulation of pain in female patient with fibromyalgia (DouFiSport): a 24-month, controlled, randomised, double-blind protocol. BMJ Open. 2019 Jan 25;9(1):e023742. doi: 10.1136/bmjopen-2018-023742.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: June 30, 2015): 110
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: October 2019
• Estimated Primary Completion Date: October 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Diagnosis of fibromyalgia is clearly established by the criteria of the American College of Rheumatology (ACR).
• Body Mass Index (BMI) between 18.5 and 24.9 kg / m² (normal weight at HAS).
• Spontaneous pain intensity greater than 3/10 on a VAS. Pain triggered by palpation must be equal to or greater than 4/10 of the EVA.
• Patients with a medical certificate to the sport.

Exclusion Criteria:

• Systemic disease, whether or not, generating pain musculoskeletal
• Heart disease, respiratory, endocrine, metabolic or neurological.
• Patients and patient pregnant lactating or planning to become pregnant within 2 years.
• Patients who have changed in the last 2 months any pharmacological treatment.
• Patients taking drugs that affect the heart rate variability
• Patients who have conditions that could affect the cortisol levels
• Patients with a psychiatric diagnosis of schizophrenia, delusional disorder and other personality disorders
• Patients taking substances affecting cortisol secretion

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT02486965
• Other Study ID Numbers: DOUFISPORT (RB 14.076)
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: University Hospital, Brest
• Study Sponsor: University Hospital, Brest
• Collaborators: Not Provided

Investigators

• Principal Investigator: Gildas L'HEVEDER, Doctor; CHRU Brest

• PRS Account: University Hospital, Brest
• Verification Date: January 2019